Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02581995
• Date of registration: 20/10/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME. AQUA
• Scientific title: Open-label Phase-4 Study to Examine the Change of Vision-related Quality of Life in Subjects With Diabetic Macular Edema (DME) During Treatment With Intravitreal Injections of 2 mg Aflibercept According to EU Label for the First Year of Treatment
• Date of first enrolment: November 19, 2015
• Target sample size: 560
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02581995
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Austria, Canada, Czech Republic, Czechia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 1 or 2 diabetes mellitus

- Diagnosis of DME secondary to diabetes mellitus involving the center of the macula
(defined as the area of the center subfield on OCT) in the study eye

- Decrease in vision determined to be primarily the result of DME in the study eye

- BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen
equivalent of approximately 20/40 to 20/320.)

Exclusion Criteria:

- Pregnancy and lactation

- Mismatch with inclusion criteria



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Macular Edema

Intervention(s)

Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Primary Outcome(s)

Change From Baseline to Week 52 in NEI VFQ-25 Total Score [Time Frame: Baseline, Week 52]

Secondary Outcome(s)

Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT) [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale [Time Frame: Baseline, Week 52]

Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP) [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score]) [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale [Time Frame: Baseline, Week 52]

Secondary ID(s)

17850

2014-005119-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02581995